The following new section was added:

New variables have been added to the following sections:

Many variable labels, notes, definitions, or examples were modified. In most cases, these modifications were to use the phrase "treatment or product" for the case when product use is not considered a treatment. In some cases a definition was added where there was none before. The type and location of revisions made are described in the following tables.

VARIABLES



Modifications made to existing Variable

Variable

Section

Label

Notes

Definition

Examples

--TRT

Section 3.1.1, The Interventions Observation Class

X

X

X


--RSDISC

Section 3.1.1, The Interventions Observation Class

X

X



--DOSFRM

Section 3.1.1, The Interventions Observation Class



X


--DOSFRQ

Section 3.1.1, The Interventions Observation Class



X


--DOSTOT

Section 3.1.1, The Interventions Observation Class



X


--DOSRGM

Section 3.1.1, The Interventions Observation Class



X


--ACN

Section 3.1.2, The Events Observation Class

X


X


--ACNOTH

Section 3.1.2, The Events Observation Class



X


--REL

Section 3.1.2, The Events Observation Class



X


--RLDEV

Section 3.1.2, The Events Observation Class



X


--SPEC

Section 3.1.3, The Findings Observation Class



X

X

ACTARMUD

Section 3.2.1, Demographics


X

RFENDTC

Section 3.2.1, Demographics


X

RFSTDTC

Section 3.2.1, Demographics


X

RFXENDTC

Section 3.2.1, Demographics

X
X

RFXSTDTC

Section 3.2.1, Demographics

X
X

SETCD

Section 5.1.2, Trial Sets



X

The following textual changes have been made:

Section #Section NamePrior Text (SDTM v2.0)New Text (SDTM v2.1)
1.2Implementation Advice for this Model

The SDTM has been designed to accommodate the broadest range of human and animal study data...

The SDTM has been designed to accommodate the broadest range of human and nonclinical study data...
1.2Implementation Advice for this Model

Individual IGs have been created to provide specific recommendations for numerous domains of data commonly collected in human, animal, and medical device studies....

Individual IGs have been created to provide specific recommendations for numerous domains of data commonly collected in human, nonclinical, and medical device studies....
1.2Implementation Advice for this Model

The following implementation guides have been published by CDISC:

  • Tobacco Implementation Guide (TIG)
2Model Concepts and Terms – Organization of the SDTM

The SDTM provides a general framework for describing the organization of information collected during human and animal studies.

The SDTM provides a general framework for describing the organization of information collected during human and nonclinical studies.
2Model Concepts and Terms – Organization of the SDTM

The primary purpose of the SDTM is to represent data about study subjects—which may be humans or animals—or medical devices.

The primary purpose of the SDTM is to represent data about study subjects (e.g., humans, animals, medical devices).

3.1The General Observations Classes

The Interventions Observation Class represents investigational, therapeutic, and other treatments that are administered to or used by a subject (with some actual or expected physiological effect). This includes treatments specified by the study protocol (i.e., "exposure").

The Interventions Observation Class represents, investigational, therapeutic, and other treatments and products that are administered to or used by a subject (with some actual or expected physiological effect). This includes treatments and products specified by the study protocol (i.e., "exposure").
5.1The Trial Design Model

The Trial Design Model defines a standard structure for representing the planned sequence of activities and the treatment plan for the trial.

The Trial Design Model defines a standard structure for representing the planned sequence of activities and plan for the trial.
5.1The Trial Design Model
  • Planned treatment arms (Section 5.1.1...
  • Planned arms (Section 5.1.1...

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